Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care (PRECEDE)

Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia.

Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense.

The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood.

Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Other: annual follow-up during 10 years

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +33 2 44 71 07 81; Email: cjadeau@ch-lemans.fr

Study Locations

• France
  • Angers, France, 49000
    • Not yet recruiting
    • Chu Angers
    • Contact: Jean-François AUGUSTO; Phone Number: 02 41 35 36 37; Email: JFAugusto@chu-angers.fr
  • Le MANS, France, 72000
    • Recruiting
    • Centre Hospitalier du Mans
    • Contact: Giorgina PICCOLI; Phone Number: 02 43 43 43 43; Email: gpiccoli@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meeting the preeclampsia criteria or one of its complications (eclampsia, HELLP syndrome) according to the ISSHP 2018 definitions within the last 5 years
• Having signed the informed consent
• Person affiliated to social security

Exclusion Criteria:

• Patient with mental disability or language barrier preventing understanding of the study or consent
• Person deprived of liberty by judicial or administrative decision
• Person under forced psychiatric care
• Person subject to a legal protection measure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patient with preeclampsia; Patient meeting preeclampsia criteria according to International Society for the Study of Hypertension in Pregnancy (ISSHP) 2018 definitions	Other: annual follow-up during 10 years; an annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of the Chronic Kidney Disease (CKD)	prevalence of the CKD is measured by the the rate of new CKD Diagnoses (according to the standard definitions)	until 10 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Estimated): May 30, 2037
• Study Completion (Estimated): May 30, 2037

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: preeclampsia; chronic kidney disease (CKD)
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Pregnancy Complications; Hypertension, Pregnancy-Induced; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CHM-2020/S8/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No